Comparison · NCT02635035-sae
Lisdexamfetamine First vs Lisdexamfetamine Second: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Lisdexamfetamine First vs Lisdexamfetamine Second: serious adverse events. Trial comparisons, record NCT02635035-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02635035-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0 | 0 | 0.184 | wilson | |
| Risk in group 2 | 0 | 0 | 0.155 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.155 | 0.184 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Lisdexamfetamine First | In this crossover study design, participants assigned to this group will receive Lisdexamfetamine first, then placebo second~Lisdexamfetamine: Vyvanse (Lisdexamfetamine Dimesylate) manufactured by Shire, is a Drug Enforcement Administration (DEA) class two,sympathomimetic amine, used for the treatment of attention-deficit hyperactivity disorder. The initial adult dosage is 30mg with allowed adjustments in increments of 10mg or 20mg at weekly intervals. Subjects are initiated on these doses and then they were titrated up by 20mg with a maximum dose of 70mg.~Placebo: Placebo looks just like Vyvanse but has no active ingredients, like a sugar pill. | 0 | 17 | EG000 |
| Group 2 | Lisdexamfetamine Second | In this crossover study design, participants assigned to this group will receive placebo first, then Lisdexamfetamine second~Lisdexamfetamine: Vyvanse (Lisdexamfetamine Dimesylate) manufactured by Shire, is a Drug Enforcement Administration (DEA) class two,sympathomimetic amine, used for the treatment of attention-deficit hyperactivity disorder. The initial adult dosage is 30mg with allowed adjustments in increments of 10mg or 20mg at weekly intervals. Subjects are initiated on these doses and then they were titrated up by 20mg with a maximum dose of 70mg.~Placebo: Placebo looks just like Vyvanse but has no active ingredients, like a sugar pill. | 0 | 21 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 11 weeks
Source ClinicalTrials.gov
Trial
- Title
- Shire SCT: Lisdexamfetamine Treatment for ADHD and SCT
- NCT number
- NCT02635035
- Phases
- PHASE2
- Conditions
- Attention Deficit Disorder, Attention Deficit Hyperactivity Disorder
- Interventions
- Lisdexamfetamine, Placebo
- Lead sponsor
- NYU Langone Health
- Results first posted
- 2021-11-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02635035?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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